NATIONAL DRUG POLICY - Fair treatment needed

We recently saw the welcome declaration that the Indian government plans “a major overhaul of the country’s drug policy that includes reducing the number of drugs under price control, doing away with the practice of periodic renewal of manufacturing licences, and making it easy to do medical and drug research in the country”.

Such an initiative, however, will need to navigate a complex system administered by a maze of entities: a health ministry that draws up the National List of Essential Medicines; a chemicals and fertilisers ministry that oversees the Department of Pharmaceuticals, which owns the National Pharmaceutical Pricing Authority; a commerce ministry that houses the Department of Indian Policy and Promotion responsible for protecting intellectual property rights (IPR).

To add to the complexities at the Centre, drug marketing approvals are issued by state governments.

It is good that the planned overhaul is to be led by the Niti Aayog and the PMO, which have the ability to span across ministries and withstand populist pressures — including simplistic parliamentary panel recommendations to extend price control to all drugs.

Such recommendations defy conventional marketplace wisdom that fixing prices of products discourages manufacturers from entering markets. Competition brings down prices, not shortsighted price-capping based upon flawed assumptions that drug price control increases access to healthcare. The biggest barrier to healthcare access is the inability to pay out-of-pocket and the lack of health insurance. Health coverage under government schemes does not extend to medicines or doctor visits. In a 2015 study, ‘Assessing the Impact of Price Control Measures on Access to Medicines in India’, the global health information and technology services company IMS Health concluded that price control has not improved access to healthcare.

On the contrary, it is detrimental to expertise-building initiatives, discourages local talent and counteracts the ‘Make in India’ initiative. The study notes that Indian drugs are among the cheapest in the world. Both price-controlled and non-price-controlled drugs are cheaper by 65 per cent and 25 per cent respectively than their counterparts in Brics states and Saarc countries.

The world over, any control or negotiation of drug prices is backed by government reimbursement policies. The benefit of bulk volume procurement also offsets the price reduction.

Internationally, countries adopt different approaches to regulating public and private markets. If countries regulate the public market, it is within the context of their particular healthcare financing systems.

Patients would be best served if India prioritised healthcare, strengthened healthcare infrastructure and focused on skill development for healthcare professionals. We should augment our financial outlay, in line with the stated objective of raising public health spend from the current 1 per cent to at least 2.5 per cent. Our pricing policies must recognise medicines as an economic investment in health rather than a cost to be incurred. Because medicines cure diseases, improve quality of life and build healthier and more productive population.

The government can fulfil its promise of Universal Health Assurance by working with the pharmaceutical industry towards effective drug procurement and distribution. Both could partner to revive the Jan Aushadhi programme and help deliver high-quality generic medicines at affordable prices to all. It is a laudable objective for the planned overhaul to facilitate “medical and drug research in the country”. We must recognise the value of innovation for Indian patients. Generic medicines exist because someone has invested in research to develop new medicines. Patented medicines feed the pipeline for generic medicines and protecting IPR is fundamental to the creation of cures that extend and improve lives.

Indeed, there can be no access to drugs that no one has yet developed. While there must be access to medicines for everyone, there must also be a return on investment to justify investment in new medicines. Drug discovery is a lengthy process and it takes 10-15 years and over $2 billion to develop a new medicine and make it available to patients, including the cost of thousands of failures. For every 5,000-10,000 compounds that enter the R&D pipeline, one ultimately makes it to the end and receives approval.

Ongoing innovation is critical for our increasing healthcare needs, and innovation comes at a cost. Innovators need the assurance that research will be rewarded. Intensive investment in the development of innovative medicines requires a predictable and transparent policy environment that will foster medical advancement.

India’s regulations must be rational, implementable and predictable. They should be protecting consumers, but also promoting global innovators and homegrown generics companies.

DISCLAIMER: The views expressed are solely of the author and ETHealthworld.com does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person/organisation directly or indirectly.

Ranjana was Director General at OPPI (Organisation of Pharmaceutical Producers of India), leading this industry body that represents the research-driven pharmaceutical companies in India and is focused on creating an environment conducive to innovation.

Ranjana was Director General at OPPI (Organisation of Pharmaceutical Producers of India), leading this industry body that represents the research-driven pharmaceutical companies Show more.. in India and is focused on creating an environment conducive to innovation.